Chemotherapy and Proton Radiation for the Treatment of Locally Advanced Lung Cancer

Locally Advanced Non-Small Cell Lung Cancer Clinical Trial

Official title:

Phase I/II Study of Combined Chemotherapy and High Dose, Accelerated Proton Radiation for the Treatment of Locally Advanced Non-Small Cell Lung Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00614484
• Other study ID #: OSR #49168
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: December 26, 2007
• Last updated: April 28, 2014
• Start date: August 1999
• Est. completion date: June 2011

Study information

• Verified date: April 2014
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effectiveness of proton beam radiotherapy combined with chemotherapy for treatment of locally advanced non-small cell lung cancer.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical stage 2, 3A or 3B (unresectable)

• Histologic evidence of non-small cell carcinoma

• Age > 18 years

• Karnofsky performance status 70 or greater

• No prior radiation to the chest

• No previous chemotherapy

Exclusion Criteria:

• Clinical stage 1 or 4

• Previous malignancies except for non-melanoma skin cancer unless disease free for > 3 years

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Locally Advanced Non-Small Cell Lung Cancer

Intervention

Radiation:
• Proton Radiation Therapy
A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. The total dose given with proton beam is 76 Gy. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.

Drug:
• Taxol
200 mg/m2, IV, for 2 cycles followed by 50 mg/m2 weekly for 5 weeks during radiotherapy.
• Carboplatin
AUC 6, IV, for two cycles followed by AUC 2 weekly for 5 weeks during radiotherapy.

Locations

Country	Name	City	State
United States	Loma Linda University Medical Center	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival.	Median survival time following treatment.	Monthly for duration of participant lifespan. Average lifespan 1-2 years	Yes
Secondary	Treatment Related Toxicities.	grade 3 or higher esophageal toxicity; Toxicity is categorized either early or late phase.; Early phase- toxicity occurring during or within 30 days s/p treatment Late phase- toxicity occurring thereafter	Monthly for duration of participant lifespan. Average lifespan 1-2 years	Yes